Brain TumorPhase 1/2NCT04085887
Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures
A Phase 1/2 study testing Panitumumab-IRDye800, Pinpoint-IR9000 endoscopic/handheld device and Explorer Air camera in people with Brain Tumor, run by Stanford University at 1 site in United States.
Trial summary
The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors. Read more about this study
- Who is it for?
- Ages 6 months to 25 years
- Conditions the study is for
- Brain Tumor
- What is being tested?
- Panitumumab-IRDye800, Pinpoint-IR9000 endoscopic/handheld device and Explorer Air camera
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects with suspected brain tumors undergoing surgical removal as their standard of care will be eligible. These may include subjects status post chemotherapy and/or radiation or subjects who have undergone diagnostic biopsy for their original diagnosis and are felt to be candidates for resection.
- Subjects must be eligible for resection as determined by the operating surgeon.
- Planned standard of care surgery
- Subject age 6 months to 25 years
- Life expectancy of more than 12 weeks
Who cannot join
- Received an investigational drug within 30 days prior to first dose of Panitumumab IRDye800
- Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
- History of infusion reactions to monoclonal antibody therapies
- Pregnant or breastfeeding
- Evidence of QTc prolongation on pretreatment ECG (greater than 440 ms in children 1 8 years or 8 to 18 year old males or greater than 460 ms in infants up to 1 year or 8 to 18 year old females)
- Magnesium, potassium and calcium < the lower limit of normal per institution normal lab values
Show all 11Show fewer
- Serum creatinine > 1.5 times upper reference range
- Other lab values that in the opinion of the primary surgeon would prevent surgical resection
- Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
- Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
- Subjects not deemed to be appropriate candidates for optimal resection of tumor based on location, involvement of eloquent brain, satellite lesions, or other factors not specifically listed here
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford Cancer Center
Stanford, California, 94304
Nancy Sweeters, 650-721-4074, nks2016@stanford.edu
Laura Prolo, MD
About this study
Official title: Phase 1/Phase 2, Open Label Study Evaluating the Safety, Dosing and Efficacy of Panitumumab IRDye800 as an Optical Imaging Agent to Detect Pediatric Neoplasms During Neurosurgical Procedures
The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.
Read the detailed description
Primary objective: is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.
Secondary Objective:
- To identify the optimal dose of panitumumab IRDye800 in pediatric patients
- To determine efficacy of panitumumab IRDye800 to detect microscopic disease and residual tumor during surgical resection of pediatric malignant brain tumors
Pediatric subjects will undergo standard of care, histopathologically-based, surgical resection of tumor 1 to 5 days after infusion of Panitumumab-IRDye800. Intraoperative imaging will be performed using an intraoperative optical imaging devices and wide-field imaging devices.
Back table imaging of the resection tissue (ex vivo) will be also performed with the wide-field device. Ex vivo imaging of the specimens prior to and during pathological assessment will be performed using the non-invasive, close field imaging device that does not violate or destroy the tissue. Additional imaging devices used solely on the back table are not included in this record, as the data is collected is not used for medical decisions and such devices are therefore not interventions.
Pediatric subjects will be followed for 30 days following their study infusion with scheduled follow up visits on the day of surgery (Day 1 5), Day 15, and Day 30.
- Conditions
- Brain Tumor
- Being tested
- Panitumumab-IRDye800, Pinpoint-IR9000 endoscopic/handheld device, Explorer Air camera, PDE-NEO-II
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panitumumab-IRDye800Drug
Panitumumab-IRDye800 is an imaging agent prepared as a drug-dye compound from panitumumab (Vectibix), a fully-humanized IgG2 monoclonal anti-epidermal growth factor receptor (EGFR) antibody, and IRDye800CW dye. Panitumumab-IRDye800 delivered intravenous (IV).
Pinpoint-IR9000 endoscopic/handheld deviceDevice
Novadaq intraoperative camera capable of exciting and detecting near infrared (NIR) dyes. Imaging will be performed on subjects during both during surgery (in vivo) and/or on the resected tissues while at the "back table" in the surgery suite (ex-vivo).
Explorer Air cameraDevice
Surgvision intraoperative camera. Imaging will be performed on subjects during both during surgery (in vivo) and/or on the resected tissues while at the "back table" in the surgery suite (ex-vivo).
PDE-NEO-IIDevice
Hamamatsu Photonics KK intraoperative camera. Imaging will be performed on subjects during both during surgery (in vivo) and/or on the resected tissues while at the "back table" in the surgery suite (ex-vivo).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1-0.006 Panitumumab-IRDye800 | Experimental | Dose: 0.006 Panitumumab-IRDye800 (mg/kg) Receives: Drug: Panitumumab-IRDye800; Device: Pinpoint-IR9000 endoscopic/handheld device; Device: Explorer Air camera; Device: PDE-NEO-II |
| Cohort 2-0.25 Panitumumab-IRDye800 | Experimental | Dose: 0.25 Panitumumab-IRDye800 (mg/kg) Receives: Drug: Panitumumab-IRDye800; Device: Pinpoint-IR9000 endoscopic/handheld device; Device: Explorer Air camera; Device: PDE-NEO-II |
| Cohort 3-0.50 Panitumumab-IRDye800 | Experimental | Dose: 0.50 Panitumumab-IRDye800 (mg/kg) Receives: Drug: Panitumumab-IRDye800; Device: Pinpoint-IR9000 endoscopic/handheld device; Device: Explorer Air camera; Device: PDE-NEO-II |
| Cohort 4-1.0 Panitumumab-IRDye800 | Experimental | Dose: 1.0 (with max cap dose 50 mg) Panitumumab-IRDye800 (mg/kg) Receives: Drug: Panitumumab-IRDye800; Device: Pinpoint-IR9000 endoscopic/handheld device; Device: Explorer Air camera; Device: PDE-NEO-II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicities (related adverse events)
Adverse events related to the agent or procedure are considered toxicities, and is assessed as the number of Grade 2 or higher adverse events which have been determined to be clinically-significant and definitely, probably, or possibly-related to the study treatment or procedure. The outcome is reported by dose treatment group (cohort) as a number without dispersion.
Measured: 30 days
Secondary outcomes (2)
Panitumumab-IRDye800 Fluorescence Intensity
Dosing of panitumumab-IRDye800 in the study participants will be assessed on the basis of fluorescence intensity, determined as the ratio of fluorescence intensity in tumor tissue to that of normal tissue. This is known as the tumor-to-background ratio (TBR). The outcome will be reported by dose treatment group (cohort) as the mean TBR with standard deviation.
Measured: 5 days
Tumor-to-background Ratio (TBR) Sensitivity and Specificity for Optimal Dose Level
The merit of Panitumumab-IRDye800 to identify pediatric tumors during surgery will be assessed as sensitivity, specificity, positive predictive value (PPV), and negative predictive value (PPV), based on the actual histopathological diagnosis for the excised lesions.
- Sensitivity is the "true positive rate" (by histopathology), expressed as a proportion (ratio)
- Specificity is the "true negative rate," expressed as a proportion
- Positive predictive value (PPV) is the proportion of tumor-positive samples that were actually cancer;
- Negative predictive value (NPV) is the proportion of tumor-negative samples that were not cancer.
Per protocol, the analysis is only conducted for those participants who were treated with the optimal dose level. Higher values indicate greater merit. The outcome will be reported per protocol for the optimal dose level as the sensitivity; specificity; PPV; and NPV, with 95% confidence interval.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study startDec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Prolo, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085887
- Sponsor's protocol ID
- IRB-49591
- Other IDs
- PEDSBRN0021, NCI-2026-04031
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2019
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/Phase 2, Open Label Study Evaluating the Safety, Dosing and Efficacy of Panitumumab IRDye800 as an Optical Imaging Agent to Detect Pediatric Neoplasms During Neurosurgical Procedures
- ClinicalTrials.gov ID
- NCT04085887
- Acronym / sponsor ID
- IRB-49591
- Conditions
- Brain Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.
Detailed description
Primary objective: is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.
Secondary Objective:
- To identify the optimal dose of panitumumab IRDye800 in pediatric patients
- To determine efficacy of panitumumab IRDye800 to detect microscopic disease and residual tumor during surgical resection of pediatric malignant brain tumors
Pediatric subjects will undergo standard of care, histopathologically-based, surgical resection of tumor 1 to 5 days after infusion of Panitumumab-IRDye800. Intraoperative imaging will be performed using an intraoperative optical imaging devices and wide-field imaging devices.
Back table imaging of the resection tissue (ex vivo) will be also performed with the wide-field device. Ex vivo imaging of the specimens prior to and during pathological assessment will be performed using the non-invasive, close field imaging device that does not violate or destroy the tissue. Additional imaging devices used solely on the back table are not included in this record, as the data is collected is not used for medical decisions and such devices are therefore not interventions.
Pediatric subjects will be followed for 30 days following their study infusion with scheduled follow up visits on the day of surgery (Day 1 5), Day 15, and Day 30.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1-0.006 Panitumumab-IRDye800 | Experimental | Drug: Panitumumab-IRDye800, Device: Pinpoint-IR9000 endoscopic/handheld device, Device: Explorer Air camera, Device: PDE-NEO-IIDose: 0.006 Panitumumab-IRDye800 (mg/kg) |
| Cohort 2-0.25 Panitumumab-IRDye800 | Experimental | Drug: Panitumumab-IRDye800, Device: Pinpoint-IR9000 endoscopic/handheld device, Device: Explorer Air camera, Device: PDE-NEO-IIDose: 0.25 Panitumumab-IRDye800 (mg/kg) |
| Cohort 3-0.50 Panitumumab-IRDye800 | Experimental | Drug: Panitumumab-IRDye800, Device: Pinpoint-IR9000 endoscopic/handheld device, Device: Explorer Air camera, Device: PDE-NEO-IIDose: 0.50 Panitumumab-IRDye800 (mg/kg) |
| Cohort 4-1.0 Panitumumab-IRDye800 | Experimental | Drug: Panitumumab-IRDye800, Device: Pinpoint-IR9000 endoscopic/handheld device, Device: Explorer Air camera, Device: PDE-NEO-IIDose: 1.0 (with max cap dose 50 mg) Panitumumab-IRDye800 (mg/kg) |
Who may qualify
- Ages
- 6 months to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Subjects with suspected brain tumors undergoing surgical removal as their standard of care will be eligible. These may include subjects status post chemotherapy and/or radiation or subjects who have undergone diagnostic biopsy for their original diagnosis and are felt to be candidates for resection.
- Subjects must be eligible for resection as determined by the operating surgeon.
- Planned standard of care surgery
- Subject age 6 months to 25 years
- Life expectancy of more than 12 weeks
Key exclusion criteria (11 listed)
- Received an investigational drug within 30 days prior to first dose of Panitumumab IRDye800
- Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
- History of infusion reactions to monoclonal antibody therapies
- Pregnant or breastfeeding
- Evidence of QTc prolongation on pretreatment ECG (greater than 440 ms in children 1 8 years or 8 to 18 year old males or greater than 460 ms in infants up to 1 year or 8 to 18 year old females)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Panitumumab-IRDye800Panitumumab-IRDye800 is an imaging agent prepared as a drug-dye compound from panitumumab (Vectibix), a fully-humanized IgG2 monoclonal anti-epidermal growth factor receptor (EGFR) antibody, and IRDye800CW dye. Panitumumab-IRDye800 delivered intravenous (IV). | Drug | Cohort 1-0.006 Panitumumab-IRDye800, Cohort 2-0.25 Panitumumab-IRDye800, Cohort 3-0.50 Panitumumab-IRDye800, Cohort 4-1.0 Panitumumab-IRDye800 |
| Pinpoint-IR9000 endoscopic/handheld deviceNovadaq intraoperative camera capable of exciting and detecting near infrared (NIR) dyes. Imaging will be performed on subjects during both during surgery (in vivo) and/or on the resected tissues while at the "back table" in the surgery suite (ex-vivo). | Device | Cohort 1-0.006 Panitumumab-IRDye800, Cohort 2-0.25 Panitumumab-IRDye800, Cohort 3-0.50 Panitumumab-IRDye800, Cohort 4-1.0 Panitumumab-IRDye800 |
| Explorer Air cameraSurgvision intraoperative camera. Imaging will be performed on subjects during both during surgery (in vivo) and/or on the resected tissues while at the "back table" in the surgery suite (ex-vivo). | Device | Cohort 1-0.006 Panitumumab-IRDye800, Cohort 2-0.25 Panitumumab-IRDye800, Cohort 3-0.50 Panitumumab-IRDye800, Cohort 4-1.0 Panitumumab-IRDye800 |
| PDE-NEO-IIHamamatsu Photonics KK intraoperative camera. Imaging will be performed on subjects during both during surgery (in vivo) and/or on the resected tissues while at the "back table" in the surgery suite (ex-vivo). | Device | Cohort 1-0.006 Panitumumab-IRDye800, Cohort 2-0.25 Panitumumab-IRDye800, Cohort 3-0.50 Panitumumab-IRDye800, Cohort 4-1.0 Panitumumab-IRDye800 |
Primary outcome
Toxicities (related adverse events)
Time frame: 30 days
Adverse events related to the agent or procedure are considered toxicities, and is assessed as the number of Grade 2 or higher adverse events which have been determined to be clinically-significant and definitely, probably, or possibly-related to the study treatment or procedure. The outcome is reported by dose treatment group (cohort) as a number without dispersion.
2 secondary outcomes
Panitumumab-IRDye800 Fluorescence Intensity
Time frame: 5 days
Tumor-to-background Ratio (TBR) Sensitivity and Specificity for Optimal Dose Level
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Brain Tumor
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Prolo, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Panitumumab-IRDye800, Pinpoint-IR9000 endoscopic/handheld device and Explorer Air camera in people with Brain Tumor, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nancy Sweeters (650-721-4074, nks2016@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicities (related adverse events) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.